Effects of a Novel Supplement on Glycemic Variability Measured by Continuous Glucose Monitoring

NCT05832463 | Completed

• 1 other identifier: DO-120043-CBS
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-cohort, crossover pilot study to determine interstitial glucose levels coincident with the consumption of a novel carbohydrate blocking supplement.

Conditions

Healthy

Keywords

Carbohydrate blocking supplement; Continuous Glucose Monitoring; Interstitial glucose levels

Outcome Measures

Primary Outcomes (4)

• Safety/tolerability (cohort 1)

  This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses. Dosage for cohort 2 will be determined

  2 weeks

• Dose determination for Cohort 2

  Dosage for cohort 2 will be determined

  2 weeks

• Glucose levels monitoring (Cohort 2)

  Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels

  2 months

• Glycemic variability (Cohort 2)

  Glycemic variability will be determined in healthy individuals.

  2 months

Secondary Outcomes (19)

• Glucose levels monitoring (Cohort 1)

  2 weeks

• Glycemic variability (Cohort 1)

  2 weeks

• Albumin (g/dL)

  2 weeks (Cohort 1), 2 months (Cohort 2)

• BUN (mg/dL)

  2 weeks (Cohort 1), 2 months (Cohort 2)

• Creatinine (mg/dL)

  2 weeks (Cohort 1), 2 months (Cohort 2)

Study Arms (2)

Experimental arm

EXPERIMENTAL

In cohort 1, participants will receive either a 250 mg mulberry leaf extract CBS dose (1 supplement capsule t.i.d. + 1 placebo capsule to preserve blinding) or a 500 mg mulberry leaf extract CBS dose (2 supplements t.i.d.) in the experimental arm and will cross over to or from the placebo arm. In cohort 2, participants will receive a 500 mg mulberry leaf extract CBS dose (2 supplement capsules t.i.d.) in the experimental arm and will cross over to or from the placebo arm.

Dietary Supplement: Carbohydrate blocking supplement (CBS)

Placebo arm

PLACEBO COMPARATOR

In Cohorts 1 and 2, participants will receive 2 placebo capsules in the placebo arm and will cross over to or from the experimental arm.

Dietary Supplement: Placebo capsule

Interventions

Carbohydrate blocking supplement (CBS) DIETARY_SUPPLEMENT

The CBS is composed of a Hypromellose outer shell, and filled with mulberry leaf extract, berberine HCl, cinnamon bark powder, and cinnamon bark essential oil. Mulberry leaf extract (Reducose) - 250 mg Berberine HCl (97%)(Berberis aristata root extract)- 25 mg Organic cinnamon powder (Cinnamon (Cinnamomum loureirii) bark powder) - 20 mg Essential oil blend (Grapefruit (Citrus paradisii) peel oil, Lemon (Citrus limon) peel oil Peppermint (Mentha piperita) aerial (leaf/stem) oil), Ginger (Zingiber officinale) root oil, Cinnamon (Cinnamomum zeylanicum) bark oil) - 5 mg

Experimental arm

Placebo capsule DIETARY_SUPPLEMENT

The placebo is composed of a Hypromellose outer shell filled with extra virgin olive oil.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• If female, negative pregnancy test
• Body mass index (BMI) ≤ 32
• HbA1C ≤ 6.4% at screening
• Fasting blood glucose level ≤ 125 mg/dL at screening
• \[COHORT 1 ONLY\] Willing and able (in the opinion of the investigator) to comply with all study requirements, including swallowing size 00 capsules (approximately 23 mm long and 8.5 mm diameter), food journaling, consumption of a standardized, high carbohydrate meal daily, CGM device application, and phlebotomy
• \[COHORT 2 ONLY\] Willing and able (in the opinion of the investigator) to comply with all study requirements, including swallowing size 00 capsules (approximately 23 mm long and 8.5 mm diameter), CGM device application, and phlebotomy
• Signed informed consent, HIPAA Authorization, and Confidentiality Agreement

You may not qualify if:

• Pregnancy within the last 60 days or currently breastfeeding
• Existence of any medical condition, significant disease or disorder, or surgery within the past 12 months that may, in the judgment of the medical provider, put the participant at risk, or affect study results, procedures or outcomes
• Existence of any medical concerns, or any finding that may, in the judgment of the staff medical provider, put the participant at risk, or affect study results, procedures or outcome
• \[COHORT 1 ONLY\] Sensitivity or allergy to gluten, sugar, peanuts, apples, strawberries, dairy, or orange juice
• Known or suspected allergy or sensitivity to essential oil, fatty oils, cellulose, or botanical products
• Currently following a ketogenic or medically prescribed diet, or have followed a ketogenic or medically prescribed diet within the last 3 months
• Arterial hypertension ≥140/90 mmHg.
• HbA1c ≥ 6.5% at screening
• Fasting blood glucose \> 125 mg/dL at screening
• Current or previous participation in any other clinical trial within the last month
• History of smoking or vaping within the last 3 months

Sponsors & Collaborators

• dōTERRA International: lead

Study Sites (1)

doTERRA International

Pleasant Grove, Utah, 84062, United States

Location

Study Officials

• Russell Osguthorpe, MD

  doTERRA International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Cohort 1 is single-blind. Participants will not know their treatment allocation in either arm of the study. Furthermore, in cohort 1, the participants may receive a 250 mg or 500 mg CBS dose, but will not be informed which they receive. In order to preserve blinding to dosage allocation, participants will be instructed to consume two capsules prior to each meal. * Participants receiving the 500 mg CBS dose will take 2 CBS capsules * Participants receiving the 250 mg CBS dose will take 1 CBS capsule and 1 placebo capsule * Participants in the placebo arm will take 2 placebo capsules Cohort 2 is double blind - participants will know that they will receive either the treatment or placebo first, but will be blinded to which they receive. All members of research staff will be blinded with the exception of a designated member
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 27, 2023
• Study Start: May 14, 2021
• Primary Completion: July 12, 2022
• Study Completion: July 15, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

US (1)